LIGHTHOUSE is the leading global provider of laser-based, non-destructive head space inspection systems.
The company has implemented a range of automated machines and manual bench top systems that help monitor
sterile processes and ensure the sterility and stability of finished pharmaceutical products.

Vendor Solution
Presentations

ISPE and Lighthouse invite you to
attend their Vendor Solution Presentation.

When: Monday, 11 April 2011Time: 13h00 - 13h30Where: In the Vendor Area

Container closure integrity plays an
important role in maintaining the sterility and stability of lyophilized products. Concerns over
patient safety, customer complaints, and the cost of investigations and product recalls have resulted in
revised regulatory guidance (e.g. Annex 1 revisions to the European Guidelines for the Manufacture of Sterile
Products). There is a corresponding drive in the industry to implement inspection systems to help
ensure the seal integrity of finished product vials.

Several industry case studies are
presented in this Vendor Session. All of these case studies involved 100% headspace inspection of
commercial batches of freeze dried product vials. In each case, the inspection activity identified
raised stopper issues which resulted in the loss of container closure integrity for a subset of samples in
the batch. Not only were vials identified that had lost closure but insight was also gained into
packaging and process issues that may have been the root cause of the raised stoppers.

Finally, concrete approaches that a
freeze dried manufacturer can take to manage the risk of raised stoppers in the process and subsequent loss
of container closure integrity in the finished freeze dried product vials are
described.

When: Tuesday, 12 April 2011Time: 13h00 - 13h30Where: In the Vendor Area

SCHOTT is supporting the efforts of pharmaceutical companies to improve production processes and the
product quality of drugs. We do this with primary packaging containers in glass and COC (Polymer) setting
standards on the market. Our focus lies on the maintenance of safety and stability of injectabilia by
offering e.g. high performance vials like SCHOTT TopLine Vials that are manufactured and inspected in
accordance with customer requirements or special solutions like SCHOTT Type I plus and SCHOTT TopLyo for
applications associated with very sensitive drugs.